The Importance of Gaining Fully Informed Consent

A Case Example

Following a mastectomy and immediate breast reconstruction, the patient underwent further breast reconstructive surgery to address asymmetry. The patient signed a consent form on the day of the surgery which outlined the procedure to take place, as well as the risks. However, the material to be used was not enclosed within this form or discussed prior to the surgery. The discussions for surgery and alterations to the plan of surgery took place moments before the operation. The material used was porcine, rather than bovine, derived acellular dermal matrix (ADM). This material conflicted with the patients religious beliefs. Post-operatively, the patient needed to undergo surgery to remove the porcine material.

The main learning points from this review stem from the following events:

  • Permission from the patient to the use of porcine material during reconstructive surgery was not obtained.
  • The patient was given a very small amount of time to absorb the implications of such material being used.
  • The likely options for treatment and risks of surgery were not thoroughly discussed with the patient.

Recommendations to Prevent Incident Recurrence and Improve Patient Safety

TMLEP’s recommendations to reduce recurrence and enhance patient safety are as follows:

  • Ensure patients and clinicians have sufficient time to consider treatment options ahead of a planned operation and that what is decided is mutually agreed by both parties. In reference to Montgomery and the GMC Guidance, this suggests that consent is a process and such information should be discussed with sufficient time, this will depend on the individual patient.

  • Ensure patients are fully informed as to what their surgery will entail, in line with the ruling in Montgomery. That is, anything that the individual patient, in the circumstances, would deem to be significant or that the medical expert should reasonably know the patient would deem significant. This will ensure that consent given is fully informed.

  • Ensure that discussion of the surgery (what it will entail, and the risks/benefits) takes place at a time when the patient is best able to understand and absorb the information. This will prevent patients from consenting to a surgery whereby they do not fully understand, or have time to digest, the implications of what they are consenting to. It will also ensure that the patients have capacity to assimilate the information required of consent.

  • Per the ruling of Montgomery, ensure that patients are fully advised of alternative treatments and ensure that they discuss all material risks with a patient when consenting them for a procedure. This also contributes to making sure that fully informed real consent is obtained, as the patient knows of all the options available.

Conclusion

In summary, this case highlights the need to gain fully informed consent and the importance that timing makes in gaining this consent. Not only is it important to provide the patient with all the relevant information (as per Montgomery) but it is also important that this is done at a time whereby the patient will have an individually sufficient amount of time to consider the implications of the treatment.

TMLEP would like to highlight the importance of gaining fully informed consent, whereby the patient is informed of material risks, alternative treatments and the risks of benefits of any alternative risks.

Important Note

This article is intended to raise awareness to clinical risk issues in an effort to reduce incidence recurrence and improve patient safety. This is not intended to be relied upon as advice. Facts have been altered to ensure this case is non-identifiable, albeit clinical learning points remain applicable.